Key words
uterus - ultrasound - ablation procedures - MR-imaging - leiomyoma
Preamble
Treating myoma using MR-guided focused ultrasound surgery (MRgFUS; synonym: MR HIFU = high-intensity
focused ultrasound) is a thermoablative procedure in which focused ultrasound, under
constant MR tomographic monitoring, heats the treated tissue in individual small volume
increments (sonications) until the planned fibroid volume has been completely denatured.
Upon completion of thermoablation, the control (contrast-enhanced MRI) indicates an
absence of contrast enhancement in the treated tissue (i. e. NPV = non-perfused volume).
The MRgFUS procedure is organ-preserving, non-invasive and can be performed on an
outpatient basis.
This treatment method is provided by only a few specialized facilities.
The aim of MRgFUS therapy is the reduction or elimination of myoma-based symptoms
among affected women. Ultrasonic treatment can achieve shrinking of a fibroid. Complete
remission of the fibroid should not be expected and is not the goal of treatment.
There is a consensus between the disciplines of gynecology and radiology that determination
of required treatment of uterine fibroids should be based on an examination and advice
by a gynecologist. Comprehensive advice regarding treatment options for symptomatic
uterine fibroids encompasses not only medication-based and surgical options, but also
non-surgical therapy options including uterine artery embolization (UAE) and MRgFUS. The
decision for or against an alternative therapy should be made taking into account
the patient’s desire for, and knowledge of, therapeutic alternatives, their chances
of success and limitations, as well as typical side effects and possible complications
(informed decision).
In Germany, Austria and Switzerland, the option of MRgFUS treatment offers the possibility
of a therapeutic procedure for patients with myoma-related symptoms which provides
further individualization of therapy in cases of uterine fibroids.
Aim of the consensus meeting
Aim of the consensus meeting
The intention of this second consensus meeting was the evaluation and integration
of the MRgFUS procedure into the therapeutic spectrum of myoma treatment. The 14 participants
in the meeting of radiological-gynecological experts, after taking into account current
literature and their own experience, and after extensive discussion, came to a consensus
between the two disciplines.
The panel of experts was aware that this was an assessment of the possibilities and
limits of a radiological therapy held in conjunction with specialists in gynecology
who do not perform the procedure themselves, but who possess expertise and experience
in the diagnosis as well as medication-based and surgical treatment of disorders of
female reproductive organs.
The group of experts composed of 6 radiologists and 8 gynecologists met on January
17, 2015 in Berlin for the second radiological-gynecological consensus meeting regarding
MRgFUS therapy included gynecologists from Switzerland and Austria.
After extensive – and somewhat controversial – discussion, the group came to a consensus
regarding the following recommendations. The consensus statement is supported by the
gynecologists and radiologists listed at the end of this work. It reflects the current
state of knowledge.
Structural prerequisites for the performance of MRgFUS- therapy
Structural prerequisites for the performance of MRgFUS- therapy
MRgFUS should be performed only at clinics possessing the requisite expertise and
experience with MRgFUS therapy. This also includes non-surgical and surgical management
of side effects and complications. In addition, there should be options to initiate
post-interventional pain management.
Examinations required prior to MRgFUS therapy
Examinations required prior to MRgFUS therapy
The choice of therapy should be based on an examination performed by a gynecologist
including vaginal and/or abdominal ultrasound (as a function of the size of the uterine
fibroid). A necessary prerequisite is the performance of a planning MRI using contrast
medium (CM), in prone position if possible. The contrast-enhanced image is also used
to assess whether, and to what degree, the fibroid is perfused.
Prior to each MRgFUS the indications for hysteroscopy and fractionated curettage must
be critically reviewed with respect to bleeding pattern, endometrium thickness and
structure. Unremarkable cytological smear findings of the uterine cervix must have
been obtained within the previous 12 months.
Likewise, prior to MRgFUS, within the context of the informed consent discussion,
the patient should be informed regarding the absence of a pre-interventional histological
confirmation of the presumed uterine fibroids, as is the case with all other organ-conserving
myoma therapies (see also the statement of the DGGG [German Society of Gynecology
and Obstetrics] “Implementation of the Medical Devices Act – Gynecological Morcellators”
dated 08/29/2014)
Indications for MRgFUS therapy
Indications for MRgFUS therapy
A symptomatic uterine fibroid is an indication for MRgFUS treatment.
The uterine fibroid must be in a position location that allows safe access to the
myoma for the MRgFUS. The presence of more than five myomas hinders the treatment.
In cases of myomas with a diameter greater than 10 cm, MRgFUS therapy should be critically
reviewed due to the large volume of the myoma and resulting extended treatment time.
MRgFUS represents an alternative to surgical and medication-based procedures as well
as UAE. The basis for the choice of therapy should be the aim of the treatment as
well as the patient’s desire. Given technical feasibility, MRgFUS represents a good
option for patients desiring a minimally-invasive procedure.
Success criteria for MRgFUS therapy
Success criteria for MRgFUS therapy
The goal of therapy using focused ultrasound should be the largest possible non-perfused
volume (NPV).
The improvement or disappearance of myoma-related symptoms should be the result of
successful MRgFUS treatment. Although a reduction in volume is desired, it is considered
a secondary therapeutic goal.
Contraindications for MRgFUS therapy
Contraindications for MRgFUS therapy
-
Suspicion of malignancy (absolute)
-
Pregnancy (absolute)
-
Acute inflammatory process (absolute)
-
Pedunculated subserosal fibroids (absolute)
-
No sufficiently accessible acoustic window for treatment (e. g. intestine in the planned
path of the ultrasound beam) (absolute)
-
Uterine fibroids with more than 5 myomas (relative, case-by-case decision)
-
Uterine myomas with diameter greater than 10 cm (relative, case-by-case decision)
-
Large scars in acoustic window (relative)
-
Myoma in posterior wall or near os sacrum (relative)
-
General contraindications with respect to MR contrast media (relative)
-
Relative and absolute MRI contraindications
Data regarding interactions between MRgFUS and ulipristal acetate is insufficient
and requires additional studies.
MRgFUS therapy for patients wishing to become pregnant
MRgFUS therapy for patients wishing to become pregnant
Previous case reports indicate that pregnancy is possible after MRgFUS and can be
successfully accomplished, but there are still insufficient data for a recommendation.
Side effects/complications of MRgFUS therapy
Side effects/complications of MRgFUS therapy
Related side effects and complications during and after MRgFUS treatment are rare:
-
Pain
-
Skin burns
-
Inflammation of subcutaneous adipose tissue and musculature of the abdominal wall
-
Paresthesia of the leg due to nerve irritation or damage
-
Deep leg vein thrombosis (very rare)
-
Bowel perforation (extremely rare).
After therapy, tissue components may be discharged vaginally. Increased and/or irregular
bleeding may occur up to approx. three months after treatment.
Post-treatment examination after MRgFUS therapy
Post-treatment examination after MRgFUS therapy
Post-treatment examination by a specialist is recommended approx. 6 months after MRgFUS. Imaging
procedures are useful (i. e. sonography in conjunction with Doppler sonography, MRI).
Further clarification is required if the therapy is unsuccessful (no improvement of
symptoms and/or size progression of the myoma), or there are abnormalities in the
imaging (increase in size of myoma(s) or uterus).
Outlook
Based upon available data and experience, a revision of recommendations for MRgFUS
therapy of myomas is planned in about two years.
Meeting participants
Dr. med. Alexander Beck/Berlin
Prof. Dr. med. Gerlinde Debus/Dachau
Prof. Dr. med. Markus Düx/Frankfurt a. M.
Prof. Dr. med. Dr. phil. Andreas Ebert/Berlin
Prof. Dr. med. Peyman Hadji/Frankfurt a. M.
Dr. med. Thomas Hess/Winterthur (Switzerland)
Dr. med. Friederike Hoellen/Lübeck
PD Dr. med. Peter Hunold/Lübeck
Dr. med. Hans-Christian Kolberg/Bottrop
Dr. med. Matthias Matzko/Dachau
PD Dr. med. Stefan Rimbach/Feldkirch (Austria)
PD Dr. med. Christoph Trumm/Munich
Participating professional associations and working groups
Participating professional associations and working groups
AGE, Arbeitsgemeinschaft Gynäkologische Endoskopie der DGGG (Gynecological Endoscopy
Working Group of the German Society of Gynecology and Obstetrics)
AGO, Arbeitsgemeinschaft Gynäkologische Onkologie der DGGG (Gynecological Oncology
Working Group of the German Society of Gynecology and Obstetrics)
Berufsverband der Frauenärzte e. V. (Professional Association of Gynecologists)
DeGIR, Deutsche Gesellschaft für Interventionelle Radiologie und minimal-invasive
Therapie (German Society for Interventional Radiology and Microinvasive Therapy)
DGGEF, Arbeitsgemeinschaft Gynäkologische Endokrinologie und Fortpflanzungsmedizin
e. V. (Working Group for Gynecological Endocrinology and Reproductive Medicine)
DGGG, Deutsche Gesellschaft für Gynäkologie und Geburtshilfe (German Society of Gynecology
and Obstetrics)
DRG, Deutsche Röntgengesellschaft (German X-ray Society)
SSVIR, Swiss Society of Vascular and Interventional Radiology